SHEA MOISTURE SPF 35 MINERAL SUNSCREEN- zinc oxide, titanium dioxide cream 
CONOPCO INC. D/B/A/ UNILEVER

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SHEA MOISTURE SPF 35 VITAMIN E & JOJOBA SEED OIL MINERAL BODY CREAM

Active Ingredients

Zinc Oxide 10%, Titanium Dioxide 3%

Purpose

Sunscreen, Sunscreen

Uses:

Warnings:

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Directions:

Reapply:

Other Information:

Inactive Ingredients:

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sorbitan tristearate, silica, stearyl/octyldodecyl citrate crosspolymer, VP/hexadecen copolymer, phenoxyethanol, magnesium sulfate, aloe barbadensis leaf juice, glycine soja (soybean) seed extract, glycerin, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, stearyl alcohol, tocopherol, avena sativa (oat) kernel extract, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, ethylhexylglycerin, citric acid.

Questions?

631-842-8800 or visit www.SheaMoisture.com

SHEA MOISTURE SPF 35 VITAMIN E & JOJOBA OIL MINERAL BODY CREAM

6 FL OZ (177mL)

NDC 64942-1741-1

Label

SHEA MOISTURE SPF 35 MINERAL SUNSCREEN 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
OAT (UNII: Z6J799EAJK)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
HEXADECYL POVIDONE (UNII: AG75W62QYU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
SOYBEAN (UNII: L7HT8F1ZOD)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
JOJOBA OIL (UNII: 724GKU717M)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1741-1177 mL in 1 TUBE; Type 0: Not a Combination Product04/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/18/2019
Labeler - CONOPCO INC. D/B/A/ UNILEVER (001375088)
Registrant - FRUIT OF THE EARTH, INC. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
FRUIT OF THE EARTH, INC.080086802manufacture(64942-1741)

Revised: 5/2020
Document Id: a61464e3-f17b-6df2-e053-2a95a90ad164
Set id: a61464e3-f17a-6df2-e053-2a95a90ad164
Version: 1
Effective Time: 20200520
 
CONOPCO INC. D/B/A/ UNILEVER